Zimmer Hip Recall

Orthopedics manufacturer Zimmer Biomet has been required to issue recalls for some of its hip implant devices due to many adverse events and injuries. Patients have experienced injuries and serious side effects such as metal poisoning that causes severe pain and instability. Notable Zimmer hip recalls have included the Zimmer Durom Cup and more recently, certain models of the Zimmer M/L taper with Kinectiv technology.

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Why Are There Zimmer Hip Replacement Lawsuits?

Zimmer Biomet has received lawsuits due to problems associated with their Durom Cup and other hip replacement products they produce. The focus is on product liability and faultiness that leads to these products injuring patients. 

Why have Plaintiffs Filed Zimmer Hip Lawsuits?

Plaintiffs claim that due to the design and manufacturing flaws of Zimmer’s products, they have experienced severe pain and complications. Many patients had to undergo revision surgeries. Some of the metal-related injuries plaintiffs have reported have included trunnionosis, which breaks down the femur and can lead to arthroplasty failure. 

Which Zimmer Products Are Associated with Zimmer Hip Lawsuits?

Products produced by Zimmer have been reported to cause problems in patients.

The main Zimmer products that have been included in lawsuits are:

  • Zimmer M/L Taper Hip Prosthesis
  • VerSys Femoral Head
  • Durom Cup

What Zimmer Hip Replacement Lawsuit Settlements Have There Been?

In 2010, Zimmer set up a $47.5 million settlement fund and began settling individual lawsuits relating to their faulty hip implants and products. An additional $314 million was used to settle around 700 cases involving the Durom Cup. 

In April 2022, Zimmer and other plaintiffs who were not satisfied with the settlement cases, around 302 lawsuits, were settled in a confidential settlement agreement with no record of how much was paid. As of March 2023, there have been no additional approved settlements or other juridical verdicts related to Zimmer’s products. 

Are There Active Zimmer Hip Replacement Lawsuits?

There are no current Zimmer class action lawsuits pending. However, there are 700 cases from a multidistrict litigation case in New Jersey that are still pending. There are no other active lawsuits as of September 2023. 

Why Do Patients Need Hip Replacement Products?

Hip replacement surgery is needed when patients may have diseased parts of their hip joint. The hip replacement surgery will take out the diseased parts and replace them with new, artificial parts. These artificial parts mimic the normal function of the hip. 

Common diseases that may cause patients to seek out hip replacement products or surgery include:

  • Arthritis including osteoarthritis and rheumatoid arthritis
  • Osteonecrosis
  • Fractured or broken hip bone

What Are Durom Cups?

Durom Cup is short for “Durom Acetabular Component.” This Cup is a metal hip socket that is used during hip replacement surgery. The metal-on-metal hip implant design is supposed to help prevent wear and tear that typically comes with traditional hip implants. 

How Do Durom Cups Work?

These cups were designed for more active patients who may need a stronger implant. The Durom Cup is inserted during hip replacement surgery and, just like other hip replacements, is designed to replace the diseased portion of the hip. The Zimmer Durom Cup is not screwed or cemented during implantation and is designed to bond directly to the patient’s hip bone. The cup is porous and is sprayed with a substance that facilitates the cup’s acceptance into the hip and the body. The intended outcome is that the patient’s hip bone will begin to grow into the shell of the cup, keeping it in place and making movement effortless. 

How Did the Durom Cups Fail?

It’s been reported by doctors and patients alike that the failure of the Durom Cup was due to faulty construction. The cup does not seal correctly to the hip socket and would often become detached from the hip socket a few years after the initial hip surgery. The detachment of the cup lead caused patients to feel severe pain and immobilization. 

What Are the Side Effects of Defective Durom Cups?

The detachment of the cup from the hipbone can lead to corrosion of the bone and tissues around the socket.

This corrosion can lead to severe side effects that include: 

  • Pain
  • Metallosis
  • Discomfort
  • Loosened medical device
  • Inflammations
  • Swelling
  • Stiffness
  • Decreased motion range

What Is Metallosis?

Metallosis is a rare medical condition that is caused by the deposition and build-up of metal debris into the soft tissue of the body. This condition is almost exclusively caused by metal-on-metal prosthetic devices such as the Durom Cup. When two metal pieces come into contact continuously, pieces of metal will fall off and stay in the soft tissue around the metal prosthetics. 

What Problems Did Defective Hip Replacements Cause?

Faulty hip implants have led to many patients being harmed. There was a wide range of problems but all of them boiled down to the discomfort and pain of the patients. Some examples include migration and early device failure. Both of these are harmful to patients because they can necessitate another surgery, which can be risky and could cause further harm to the patient.

How Did Migration Issues Impact Patients?

Patients who received hip replacement procedures with Zimmer’s products may have had issues with the product due to migration. Migration is when the patient is moving and the bones, tissues, and devices, such as the Durom Cup, interact in a harmful way. They will begin to rub against one another, leading the Durom Cup to shift and even allow metal particles to shed from the device and lodge into the soft tissues. This can cause stress on the hip joints as well as friction between joints and bones, leading to severe pain and potential fractures. 

How Did Early Device Failures Impact Patients?

Early failures are device failures that occur within five years of the initial hip surgery. When early failures occur often, it’s an indication that the device is faulty. 

Early failures associated with Zimmer products were happening because of patients’ reactions to the metal debris that was building up in their tissue. These reactions were painful and often lethal, causing doctors to perform correction surgeries to fix the faulty implant. 

Were Physicians Adequately Instructed in Installing Hip Replacements?

When Zimmer created the Durom Cups and began marketing them and manufacturing them, they only came with a simple aid guide. This guide was marketed by Zimmer as the only guide the doctors would need in order to install the Durom Cup. 

However, after many patients had complained about their pain and had to receive corrective surgeries, it was clear that this simple guide was not enough training to properly install the cup. Surgeons in the United States were encouraged to stop the installation of Durom Cups until a more extensive training program was in place and they were able to receive such training. 

Which Zimmer Products Were Recalled?

Zimmer has been voluntarily recalling devices since 2008-2018. These recalls can be because of inadequate installation instructions, migration issues, early device failures, and missing components. However, as indicated through the lawsuits, Zimmer’s recalled products have been linked to numerous medical problems. 

A list of Zimmer’s recalled products includes:

  • Durom Cup
  • VerSys
  • Mayo Hip
  • Longevity
  • NexGen knee replacement, MDL #2272
  • Persona Knee

Why Were Zimmer’s Hip Replacements Recalled?

Zimmer’s hip replacement devices were causing increasing problems in the patients who underwent hip replacement surgery and used Zimmer’s products. Patients who used Zimmer’s hip replacement products claimed that within only a year or two after the surgery, they would experience severe pain and immobility. Since the initial surgery proved to be unsuccessful due to the faulty Zimmer products, many had to undergo revision surgeries to fix the mistake. 

This led to Zimmer voluntarily recalling their devices starting in 2008. 

What Are the FDA’s Warnings About Durom Cups?

The FDA has released a Class II Device Recall on Durom Cups. A Class II recall regards a situation in which the use of or exposure to this product may cause temporary or reversible adverse health effects. 

The date this recall was posted was July 22. 2008 and it was determined that the cause was that the labeling was false and misleading. In the report, the FDA states that Zimmer’s instructions for the use and the surgical technique were inadequate, leading to patients getting injured.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.